Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 233-302-8 | CAS number: 10109-95-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline study following a previous guideline version
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Principles of method if other than guideline:
- Study was performed according to a previous guideline version. Following this protocol only a single dose was tested. This test dose was accurately determined in a dose range finding study in order to find the highest administrable non lethal dose level.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2,5-dianilinoterephthalic acid
- EC Number:
- 233-302-8
- EC Name:
- 2,5-dianilinoterephthalic acid
- Cas Number:
- 10109-95-2
- Molecular formula:
- C20H16N2O4
- IUPAC Name:
- 2,5-bis(phenylamino)benzene-1,4-dicarboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): 2,5-Dianilino Terephthalic Acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain specifics: Hoe: NMRKf (SPF71)
- Source: Hoechst AG, breeding colony
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 27-37 g, females: 24-31 g
- Housing: in groups of five in Macrolon(R) cages on softwood granulate, in fully air-conditioned rooms
- Diet (e.g. ad libitum): rat/mouse diet Altromin 1324, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: sesame oil
- Concentration of test material in vehicle: 30 % (w/v)
- Amount of vehicle (if gavage or dermal): 10 ml/kg body weight
- Purity: quality according to Ph. Eur. III - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
30 % was the highest concentration achievable in sesame oil - Duration of treatment / exposure:
- single oral administration
- Frequency of treatment:
- single oral administration
- Post exposure period:
- killing at 24 hours (dose group, negative control and positive control), 48 hours (dose group and negative control) or 72 hours (dose group and negative control) after administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3000
Basis:
nominal conc.
mg/kg body weight
- No. of animals per sex per dose:
- 5 males and 5 females (10 animals) per dose group and killing time
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 50 mg/kg body weight cyclophosphamide (endoxan, 5 males and 5 females)
Examinations
- Tissues and cell types examined:
- 1000 polychromatic erythrocytes from the femoral bone marrow of each animal
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES:
Animals were killed 24, 48 or 72 h after application
DETAILS OF SLIDE PREPARATION:
Femora were removed and the bones freed of muscle tissue. The proximal ends of the femora were opened and the bone marrow flushed into the centrifuge tube. The mixture was centrifuged for 5 minutes at 1200 rpm and the supernatant discarded. One drop of the thoroughly mixed sediment was
smeared on a slide.
Staining procedure:
- 5 minutes in methanol
- 5 minutes in May-Grünwalds solution
- brief rinsing twice in distilled water
- 10 minutes staining in 1 part Giemsa solution to 6 parts buffer solution, pH 7.2
- rinsing in distilled water
- drying
- coating with Entellan - Evaluation criteria:
- A substance is considered as positive if there is a significant increase in the number of micronucleated polychromatic erythrocytes at least at one point of time. A test substance producing no significant increase in the number of micronucleated polychromatic erythrocytes at any counting time is considered non-mutagenic in this system.
- Statistics:
- The number of polychromatic erythrocytes with micronuclei occurring in 1000 polychromatic erythrocytes, and the number of normocytes with micronuclei occurring in 1000 normocytes, were evaluated statistically; comparison of dose groups with the simultaneous control group was performed according to Wilcoxon (paired, one-sided, increase)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- A RANGE-FINDING STUDY was conducted to determine the highest administrable non lethal dose level.
RESULTS OF RANGE-FINDING STUDY
- Dose range: 3000 mg/kg body weight
- Clinical signs of toxicity in test animals: intensive yellow coloured urine
- Lethality: 0 of 3 males and 0 of 3 females
RESULTS OF DEFINITIVE STUDY
- All animals survived after application of 3000 mg per kg bodyweight.
- Clinical signs: urine intensive yellow coloured and faeces violet coloured (males only). 48 hours after application all animals were free of clinical signs.
- Macroscopic findings: stomach and intestinum contents were violet coloured in some animals
- Induction of micronuclei (for Micronucleus assay): no statistically significant increase of micronucleated polychromatic erythrocytes in dosed animals
- Ratio of PCE/NCE (for Micronucleus assay): unaffected by the test compound
Any other information on results incl. tables
Mean mutation indices in polychromatic erythrocytes:
Sex |
Sampling after Dosing |
Number of Animals |
Vehicle control group |
Dose group |
Positive control group |
Male |
24 h |
5 |
1.0 |
2.2 |
31.2 |
Female |
24 h |
5 |
1.0 |
2.0 |
32.4 |
Male |
48 h |
5 |
1.0 |
0.2 |
- |
Female |
48 h |
5 |
1.0 |
0.5 |
- |
Male |
72 h |
5 |
1.0 |
0.3 |
- |
Female |
72 h |
5 |
1.0 |
0.6 |
- |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The results indicate that, under the conditions of the present study, the test item is not mutagenic in the micronucleus test. - Executive summary:
The test item was tested in the micronucleus test according to OECD guideline 474. The test compound was suspended in sesame oil and dosed once orally at 3000 mg per kg body weight to male and female mice, based on the results of the previously conducted dose range finding assay. Animals were killed 24, 48 or 72 hours after administration.
EndoxanR was used as positive control substance and was administered orally at a dose of 50 mg per kg body weight.
The number of polychromatic and normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with the test item and was statistically not different from the control values.
EndoxanR induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity af the system.
The results indicate that, under the conditions of the present study, the test item is not mutagenic in the micronucleus test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.